The present invention relates to a medical treatment device for the application of cryo, thermal, and compression therapy to an injured or traumatized region of the face and jaw. More specifically, the present invention is directed to a garment device to treat the tempomandibular joint and its disorders with cryo, thermal, and/or compression therapy, and to treat the maxillo-mandibular regions with cryo compression therapy, with an integral and portable unit worn by the patient.
A variety of medical conditions which can cause inflammation of the joint or masticatory muscles can have immediate relief by reduction of the temperature to the region. The effect of cooling and compression on traumatically injured soft and hard tissues has been well known and documented in the medical, dental and surgical literature. Cold application with compression reduces edema (swelling) and the flow of blood to the inflamed tissue of injured muscles, tendons, and ligaments and has been used for over a century. Thus the art teaches various configurations for ice pack compresses or introduction of a cooling medium with compression. On the other hand, a variety of medical conditions can create reduction of tissue blood flow, ischemia, and muscle ache, myalgia, to a region such as the masitcatory (chewing) muscles. The literature supports that pain resulting from such a condition is relieved by thermal application with heating to the injured muscles. Application of heat to such areas increases the blood flow to the region and promotes healing.
Temporomandibular disorders (TMD) refer to a collection of medical and dental conditions affecting the temporomandibular joint (TMJ), that being the joint near the temple and the lower part of the jaw, and/or the muscles of mastication (chewing), as well as contiguous components. Although specific etiologies such as degenerative arthritis and trauma underlie some TMD, as a group these conditions have no common etiology or biological explanation and comprise a hetereogeneous group of health problems whose signs and symptoms are overlapping, but not necessarily identical. Consequently, depending on the condition, application of heat, cold, or compression or a combination thereof, may or may not be beneficial. For example, in the case of direct trauma to the TMJ and for reduction of post-operative swelling and hemorrhage, cryo compression treatment to specific areas associated with the TMJ can have a favorable effect. However, for TMJ degenerative joint disease (DJD) and arthritic conditions, thermal therapy only should be delivered to the TMJ region. In the case of post-traumatic hemorrhage to the maxillofacial (cheek) region, post-operative elective maxillo-mandibular osteomies and removal of wisdom teeth, cryo compression therapy is effective.
Although various garments and bandages for use on the facial region have been proposed, the prior art has not specifically addressed the use of an appropriate device for treating the above TMJ disorders, or more generally, the areas of the TMJ and lower jaw.
For example, U.S. Pat. No. 4,190,054 (Brennan) discloses a bandage in the form of a complete face mask necessary to hold facial tissues after cosmetic surgery to prevent sagging. The bandage incorporates a plurality of attachment points located on its outside for conventional hot or cold packs.
U.S. Pat. No. 5,188,103 (Smith) teaches the use of an adjustable facial dressing for compression and/or support with means to apply thermal or cryo treatment via a pouch for conventional hot or cold packs.
U.S. Pat. No. 3,871,381 (Rolonski) teaches the use of a pressurized volatile refrigerant cooling a serpentine channel in a flexible device through a controlled flow valve. Rolonski discloses a device embodied in an application for a race horse, a human hand, foot, and knee with the provision for only compression and cooling.
U.S. Pat. No. 5,658,324 (Bailey, Sr. et al.) similarly discloses an apparatus for providing cryo therapy and controlled compression using a maze with a plurality of blind pockets forming traps. The maze terminates in a port inflating a bladder with the vaporized refrigerant to a specified pressure.
U.S. Pat. No. Re. 34,883 (Grim) discloses an orthopaedic back support comprising an elastic material which carries a gel pad with an adjustable heating element and an air bladder. The gel material is specifically suited to orthopaedic applications to comfort the patient. The heating element contained therein forms a separate pouch that is closest to the patient""s back and which covers the air pumped inflatable layer underneath.
U.S. Pat. No. 5,449,379 (Hadtke) is directed to an apparatus for applying heat or cold and pressure to an injured area with three layers of flexible material. An inflation chamber is formed for a pressurized gas to provide compression. The particular compressed gas employed determines the temperature of the wrap. Heating can be provided in communication with same inflation chamber via a two phase mixture of gases to produce an exothermic reaction.
A disadvantage to the prior art is that none of the devices is suitable for treating TMD because none of the devices have a specific anatomical design which can render controlled hot and cold compression to the masticatory muscles. In addition, none of the devices are designed to provide a sustainable heat source to the TMJ region readily controllable by the patient Moreover, the design of other types of cryo/thermal compression devices appropriate for other medical applications do not have the ability to provide a sustainable cold source, controllable by the patient, without either having to provide a different gas supply or to replace the thermal system with the cryo system. Furthermore, application of heat by the use of two-phase gases to produce an exothermic reaction as disclosed by Hadtke produces compression which is not beneficial in the healing phase as it can reduce the blood supply to the injured tissue which can be counterproductive. As such, none of the prior devices are appropriate to the pathophysiology of the disease process within the joint and muscles associated with the TMJ and maxillomandibular region.
Another disadvantage to other cryo/thermal compression systems is any inflation to provide compression ultimately causes the flexible device to bulge, which can render a device applied to the TMJ and maxillomandibular region less effective and cumbersome to the patient.
Yet another disadvantage to the prior art systems which employ any combination of compression with cryo and/or thermal therapy is the complexity of design associated with multi-channeled inflation chambers to control the contact of the device with a cryo gas and temperature adjacent to the patent.
What is desired, therefore, is device suitable in anatomical design to apply both cryo, thermal and compression therapy effective for specific treatment of TMJ disorders, and the maxillomandibular region of a patient. What is also desired is a device, wherein the temperature and pressure can be readily controlled and sustained by the patient without having to forego either cryo therapy, or thermal therapy with the same device, and wherein the patient can change from either cryo therapy with compression, or thermal therapy, without having to after the device. What is also sought is device for treating TMJ disorders with improved compression, wherein bulging of the inflated device is reduced.
Accordingly, it is the object of the present invention to provide a device to treat the temporomandibular joint (TMJ) and maxillomandibular region of a patient with the option of cryo, thermal, or compression therapy in a single integral unit.
It is another object of the present invention to provide a device to treat the TMJ and maxillomandibular region of a patient anatomically designed to provide cryo and compression therapy and/or thermal therapy specifically to the angle of the lower jaw where most traumatic injuries, such as mandibular fractures, occur and/or to the angle of the jaw and the TMJ.
It is a further object of the present invention to provide a device to treat the TMJ and maxillomandibular region of a patient with a sustainable heat source readily controlled by the patient.
It is another object of the present invention to provide a device to treat the TMJ and maxillomandibular region of a patient with a sustainable cold source, controlled by the patient, without either having to provide a different gas supply or to replace a thermal system with a cryo system.
It is a further object of the present invention to provide a device to treat the TMJ and maxillomandibular region of a patient with an inflation bladder that is simpler in construction and more economical to manufacture than other devices that employ cryo compression therapy.
Another object of the present invention is to provide a device to treat the TMJ and maxillomandibular region of a patient that is constructed to direct compression to the appropriate anatomical area for treating TMJ disorders and the maxillomandibular region that resists bulging rendering the device more effective or less cumbersome to the patient.
Yet a further object of the present invention is to provide a method to use a device to treat a patient with the option of cryo, thermal or compression therapy appropriate to the pathophysiology of disease processes within the joint and muscles associated with the TMJ and maxillomandibular regions.
To overcome the deficiencies of the prior art and to achieve some of the objects and advantages listed above, the present invention provides: a device to treat the temporomandibular joint of a patient constructed for cryo, thermal, and compression therapy, a device to treat maxillomandibular region of a patient constructed for cryo and compression therapy, a method to use a device to treat the maxillomandibular region of a patient with cryo, and compression therapy, and a method to use a device to treat the temporomandibular joint of a patient with cryo thermal and compression therapy.
The device to treat the temporomandibular joint of a patient according to the invention comprises: a fabric layer anatomically designed to contact the temporomandibular joint, the chin and the parietal area of a patient, having an extension around the angle of the jaw and the temporomandibular joint; an inflatable layer to direct compression to the temporomandibular joint, the inflatable layer attached to the fabric layer, and a heater for heating the masticatory muscles, the temporomandibular joint and temporal regions, the heater attached to the fabric layer.
The device to treat the maxillomandibular region of a patient according to the invention comprises: a fabric layer anatomically designed to contact the maxillomandibular region, the chin and the parietal area of a patient, having an extension around the angle of the jaw; an inflatable layer to direct compression to the maxillomandibular region; the inflatable layer attached to the fabric layer; and a hard plate placed on the fabric layer, wherein the plate is lateral to the patients skin to resist bulging of the inflatable layer when inflated.
In another embodiment, the invention provides a device to treat the maxillomandibular region or the temporomandibular joint of a patient further comprising a conductive layer covering the inflatable layer.
The invention in one of its aspects also provides a method to use a device to treat the maxillomandibular region of a patient with cryo, and compression therapy. Such a method comprises the steps of wrapping a device to contact the maxillomandibular region, the chin and the parietal area of a patient by use of an extension around the angle of the jaw; inflating the device to apply a pressure to the maxillomandibular region; and cooling a conductive layer of the device, wherein the conductive layer contacts the maxillomandibular region.
In another aspect, the invention provides a method to use a device to treat the temporomandibular joint of a patient with cryo and compression therapy comprising the steps of wrapping a device to contact the temporomandibular joint, the chin and the parietal area of a patient by use of an extension around the angle of the jaw; inflating the device to apply a pressure to the temporomandibular joint region; cooling a conductive layer of the device, wherein the conductive layer contacts the temporomandibular joint region; and heating the device to supply direct heat to the masticatory muscles, the temporomandibular joint and temporal regions.